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Trial record 28 of 670 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Marrow Diseases"

Surgical Treatment of Long Bone Metastases (MTC)

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ClinicalTrials.gov Identifier: NCT03188926
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Costantino Errani, Istituto Ortopedico Rizzoli

Brief Summary:
To provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

Condition or disease Intervention/treatment
Bone Metastases Surgery Procedure: intramedullary fixation or endoprosthetic reconstruction

Detailed Description:
The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Surgical Treatment for Long Bone Metastases With Intramedullary Nail or Endoprosthetic Reconstruction
Actual Study Start Date : January 4, 2016
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: intramedullary fixation or endoprosthetic reconstruction
    Surgical treatment of impending or pathologic fracture in the extremities


Primary Outcome Measures :
  1. Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction [ Time Frame: 1 year ]
    The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary nail versus endoprosthetic reconstruction with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction


Secondary Outcome Measures :
  1. Survival in patients undergoing surgery for metastatic bone disease [ Time Frame: 1 year ]
    Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction
Criteria

Inclusion Criteria:

  • bone metastases of the extremity

Exclusion Criteria:

  • bone metastases of the spine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188926


Contacts
Contact: Costantino Errani, MD, PhD 0039 051 6366103 costantino.errani@ior.it
Contact: Davide Donati, MD 0039 051 6366012 davidemaria.donati@ior.it

Locations
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Costantino Errani, MD, PhD    0039 051 6366103    costantino.errani@ior.it   
Contact: Davide Donati, MD    0039 051 6366012    davidemaria.donati@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Study Director: Davide Donati, MD Istituto Ortopedico Rizzoli

Responsible Party: Costantino Errani, MD, PhD, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03188926     History of Changes
Other Study ID Numbers: 0026106
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publish a manuscript in international journal

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases